Atlas FDA

KNK

118 FDA 510(k) clearances · Product code

42 daysmedian time to decision
109 days90th percentile
118clearances measured

FDA profile

Official device name
Acid, Uric, Uricase (Colorimetric)
Device class
Class I (low risk)
Regulation
21 CFR 862.1775
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2011: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
URIC ACID MODEL 3P39 (K102568)Abbott Laboratories2011-05-06
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (K062862)Olympus America, Inc.2007-04-06
VITALAB URIC ACID REAGENT (K040467)Clinical Data, Inc.2004-03-08
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (K031044)Clinical Data, Inc.2003-07-15
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022096)Bayer Diagnostics Corp.2003-03-18
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (K023550)Wiener Laboratories Saic2002-12-09
JAS URIC ACID LIQUID REAGENT (K012038)Jas Diagnostics, Inc.2001-08-21
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 (K010421)Wiener Laboratories Saic2001-04-13
WAKO L-TYPE UA F TEST (K993469)Wako Chemicals USA, Inc.1999-11-09
URIC ACID, MODEL UA112-01 (K991247)A.P. Total Care, Inc.1999-05-25
CARESIDE URIC ACID (K981604)Careside, Inc.1998-06-25
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT (K970919)Beckman Instruments, Inc.1997-05-21
URIC ACID REAGENT (K970867)Derma Media Lab., Inc.1997-04-21
URIC, UA, OR URIC ACID (K971133)Carolina Liquid Chemistries Corp.1997-04-14
URIC ACID (LIQUID) REAGENT SET (K970560)Pointe Scientific, Inc.,1997-03-11
URIC ACID-SL ASSAY CATALOGUE NO. 237-60 (K961586)Diagnostic Chemicals , Ltd.1996-07-23
URIC ACID CATALOGE# 220-93/94/97 (K955496)Diagnostic Chemicals , Ltd.1996-02-23
URIC ACID QVET (K943002)Prisma Systems1994-12-02
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) (K932728)Eastman Kodak Company1994-04-25
IL TEST URIC ACID (K931350)Instrumentation Laboratory CO1993-10-01
URIC ACID ENZYMATIC COLORIMERIC KIT (K923503)Randox Laboratories, Ltd.1993-07-22
OLYMPUS URIC ACID REAGENT (K925113)Olympus Corp.1993-01-26
MILES AUTO METH DETERMIN OF URIC ACID IN URINE (K924129)Heraeus Kulzer, Inc.1992-09-22
SYNERMED 600 NM URIC ACID REAGENT KIT (K923414)Synermed, Inc.1992-09-22
OLYMPUS URIC ACID REAGENT (K922756)Olympus Corp.1992-07-17
ROCHE REAGENT FOR URIC ACID--MODIFICATION (K922762)Roche Diagnostic Systems, Inc.1992-07-09
URIC ACID REAGENT SET (K914158)Tech Intl. Co.1992-02-21
URIC ACID (URICASE) REAGENT, UNIVERSAL (K912028)Enzyme Technology, Inc.1991-12-18
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 (K913706)Em Diagnostic Systems, Inc.1991-09-27
SYNERMED URIC ACID REAGENT KIT (K903727)Synermed, Inc.1990-09-27
COBAS READY PROFILE 2 REAGENT STRIP (K896225)Roche Diagnostic Systems, Inc.1990-06-26
URIC ACID TEST KIT (K901001)Elite Technology, Inc.1990-05-23
WAKO(TM) AUTOKIT URIC ACID (K901544)Wako Chemicals USA, Inc.1990-05-14
TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC (K901693)Technicon Instruments Corp.1990-04-25
COULTER URIC ACID REAGENT (K897161)Coulter Electronics, Inc.1990-03-01
ABBOTT SPECTRUM URIC ACID REAGENT KIT (K896954)Abbott Laboratories1990-02-23
COBAS READY URIC ACID REAGENT (K896227)Roche Diagnostic Systems, Inc.1990-02-16
MODIFIED PARAMAX URIC ACID REAGENT (K896521)Baxter Healthcare Corp1990-02-16
URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS (K895821)Catachem, Inc.1989-12-05
URIC ACID PAP (K895665)Boehringer Mannheim Corp.1989-10-23
ROCHE REAGENT FOR URIC ACID (K894101)Roche Diagnostic Systems, Inc.1989-09-05
URIC ACID TEST ITEM NUMBER 65422 (K894287)Em Diagnostic Systems, Inc.1989-08-28
URIC ACID REAGENT (PROCEDURE NUMBER 686) (K893416)Sigma Chemical Co.1989-06-23
AMRESCO URIC ACID REAGENTS #7628 (K892395)American Research Products Co.1989-05-24
URIC ACID KIT, CODES 4825400 AND 4825050 (K890319)American Research Products Co.1989-04-12
URIC ACID TEST (URIC) ITEM #65620 (K884704)Em Diagnostic Systems, Inc.1989-01-23
URIC ACID REAGENT (PRODUCT #88219) (K883404)Hichem Diagnostics1988-09-13
BIOTROL URIC ACID ENZYMATIQUE TRINDER (K883428)Biotrol, USA, Inc.1988-09-13
URIC ACID REAGENT SET (K880277)Tech-Neal Scientific, Inc.1988-04-18
WAKO AUTOKIT URIC ACID (K880731)Wako Chemicals USA, Inc.1988-03-24
PARAMAX URIC ACID REAGENT (K873456)Baxter Healthcare Corp1987-11-23
URIC ACID PAP (K873363)Boehringer Mannheim Corp.1987-10-19
TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER (K871892)Technicon Instruments Corp.1987-06-17
THE URIC ACID REAGENT SET (K871902)Macomb Biotechnology, Inc.1987-06-03
COLORIMETRIC URIC ACID REAGENT SET (K871417)Biochemical Trade, Inc.1987-04-22
EASY-TEST URIC ACID (URIC) #16606 (K870868)Em Diagnostic Systems, Inc.1987-03-19
FAST URIC ACID (K870632)Sclavo, Inc.1987-03-13
IQ URIC ACID TEST (K864341)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-12-16
URIC ACID (K863924)Tech-Co, Inc.1986-11-24
URIC ACID TEST (K864119)U. S. Diagnostics, Inc.1986-10-29
URIC ACID PROCEDURE (K863251)Data Medical Associates, Inc.1986-09-26
URICMETER (K863113)J. D. Assoc.1986-09-09
REFLOTRON URIC ACID (K861831)Boehringer Mannheim Corp.1986-07-11
KING DIAGNOSTICS URIC ACID TEST (K862208)King Diagnostics, Inc.1986-07-08
URIC ACID PROCEDURE (K861660)Data Medical Associates, Inc.1986-06-13
ENZYMATIC URIC ACID REAGENT (K860732)Trace Scientific , Ltd.1986-04-16
EASY-TEST URIC ACID (URIC), #67516/93 (K860916)Em Diagnostic Systems, Inc.1986-04-07
URIC ACID REAGNET SET (TRINDER) (K860477)Sterling Diagnostics, Inc.1986-04-03
IN-VITRO TEST DETERMINATION OF URIC ACID (K854185)Clinical Data, Inc.1985-11-25
URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS (K853825)Catachem, Inc.1985-09-30
URIC ACID REAGENT (K853357)Sigma Diagnostics, Inc.1985-08-19
UN(UREASE)REAGENT UN(A-KETO)REAGENT (K851991)Alpkem Corp.1985-05-29
UA(URICASE) REAGENT (K852004)Alpkem Corp.1985-05-29
LINEAR ENZYMATIC URIC ACID SYSTEM (K843938)Simmler, Inc.1984-10-30
FOCUS URIC ACID (K844011)Abbott Laboratories1984-10-30
SYSTEMATE URIC ACID, HEM 67220 (K843325)Em Diagnostic Systems, Inc.1984-09-13
AXIOM STABLE II URIC ACID TEST (K842442)Axiom, Inc.1984-08-16
TOYO JOZO URIC ACID TEST (K842103)Advocacy International, Ltd.1984-08-12
URIC ACID ASSAY KIT (K842246)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
TDX REA URIC ACID (K841702)Abbott Laboratories1984-05-31
URIC ACID REAGENT SET ENZYMATIC (K841049)Medical Specialties, Inc.1984-05-01
URIC ACID REAGENT (K840781)American Dade1984-04-13
URIC ACID REAGENT SET (K834045)Sterling Biochemical, Inc.1984-01-30
COMPUR* EASY TOUCH URIC ACID REAGENT (K832785)Worthington Diagnostic Systems1983-10-14
DATA-ZYME URIC ACID PROCEDURE (K831983)Data Medical Associates, Inc.1983-08-08
URIC-ACID TEST ENZYMATIC COLORIMETRIC (K831864)Stanbio Laboratory1983-07-22
LINEAR ENZMATIC URIC ACID SYSTEM (K831398)Simmler, Inc.1983-06-08
URIC ACID COLORIMETRIC DETERMINATION (K830679)Dow Instruments & Reagents, Inc.1983-04-06
URIC ACID TEST (K823846)Scalavo, Inc.1983-01-24
URIC ACID REAGENT (K822913)Ac Biochemical Laboratories, Inc.1982-12-20
URICACID (K821741)Biodynamics Corp.1982-07-02
BECKMAN URIC ACID REAGENT (K821812)Beckman Instruments, Inc.1982-07-02
URIC ACID REAGENT SET(ENZYMATIC (K821214)Omega Medical Electronics1982-05-21
COLORIMETRIC URIC ACID REAGENT SET (K820632)Biorent Diagnostic, Inc.1982-03-25
URIC-ACID (K813511)Medical Analysis Systems, Inc.1981-12-31
URIC ACID SYSTEM PACK TEST (K812978)Boehringer Mannheim Corp.1981-11-06
URICAR (K812700)Hi Chem, Inc.1981-11-05
URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM (K812641)Reagents Applications, Inc.1981-10-02
URIC ACID REAGENT SET (K812430)Pointe Scientific, Inc.,1981-09-09
URIC ACID TEST (K811810)Environmental Chemical Specialties1981-07-15
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